SC 28 Annex : Checklist on Compliance with HOKLAS Requirements - Haematologysc 28 Annex

SC 28 Annex : Checklist on compliance with HOKLAS requirements - HaematologySC 28 Annex – Page 1 of 29

Issue No. 3

HOKLAS Requirement / Clause / * / Y / N / NA / QM Clause / Remarks / Questions to be asked at laboratory

Management requirements

Quality and technical records

/ 4.13

Are there documented policies and operating procedures to guide the proper storage and handling of records (such as retrieval and disposal) so as to ensure their integrity and confidentiality?

/ 4.13.1

Technical requirements

Personnel

/ 5.1
Are there personnel policies and job descriptions that define qualifications and duties for all laboratory staff? / 5.1.2 / ●
Are staff numbers adequate and qualifications appropriate? / 5.1.2, 5.1.4g, 5.1.5 / ●
Does staff have appropriate and adequate training? / 5.1.2 / ●
Accommodation and environmental conditions / 5.2
Facilities
Does the laboratory have adequate and orderly space for:
-workbench? / 5.2.1 / ●
-equipment, e.g. microscopy and/or photomicroscopy, photographic processing or darkroom(if this procedure is used for karyotyping), fume cupboard (for reagent preparation) and Class II safety cabinet? / 5.2.1 / ●
-administrative and clerical work? / 5.2.1 / ●
-storage(including refrigerated storage)? / 5.2.9 / ●
Does the laboratory have adequate:
-fume-hoods or fume-cupboards? / 5.2.2 / ●
-lighting? / 5.2.4 / ●
-ventilation? / 5.2.4 / ●
-water supplies (tap, deionized, or distilled)? / 5.2.4 / ●
-drainage or sewage disposal; are procedures for solvent disposal andprocedures for biological waste disposal all conform to relevantlocal authorities’ requirements? / 5.2.4 / ●
-ambient temperature and humidity control (particularly where sensitive instruments are in use)? / 5.2.5 / ●
Are reagents correctly kept according to manufacturer recommendations, especially where special storage conditions are required (refrigeration, flammable store, dark storage)? / 5.2.9 / ●
Electrical
Are adequate power points available (the use of double adapters and long extension cords is undesirable)? / 5.2.5 / ●
Is the electricity voltage monitored or checked periodically? / 5.2.5 / ●
Are voltage regulators / stabilizers / uninterruptible power supply used on instrumentsthat require these items? / 5.2.5 / ●
Is essential electrical supply available? / 5.2.5 / ●
Safety
Does the laboratory comply with the professional, statutory and legislative safety requirements? / 5.1.4m, 5.2.2 / ●
Does the laboratory adopt and implement universal precaution guidelines? / 5.1.4m, 5.2.2 / ●
Laboratory equipment / 5.3
Is equipment adequate for the range and number of tests beingperformed? / 5.3.1 / ●
Is a list of all major equipment used available? / 5.3.1 / ●
Is there planned preventive maintenance for allinstruments in use? / 5.3.2 / ●
Is there instruction and documentation for checking instruments? / 5.3.2, 5.3.4 / ●
Is the temperature checked and recorded regularly for temperature-controlled devices, e.g., water-baths, incubators, refrigerators and freezers? / 5.3.2, 5.3.4 / ●
Are function and performance of instruments documented in a manner that may reveal trends of malfunctions? / 5.3.4 / ●

Is there evidence of active review of instrument maintenance,function and temperature on all shifts?

/ 5.3.4 / ●
Are there documented protocol and schedule for checkingcentrifuge speed? / 5.3.4 / ●
Are the operating temperature ranges defined for each temperature-controlleddevice? / 5.3.5 / ●
Reagents
Are reagents properly labelled with content,concentration (if applicable), date of preparation or date opened, and expiry date? / 5.3.2 / ●
Are reagents used within their shelf life? / 5.3.2 / ●
Are outdated reagents quarantined or discarded? / 5.3.2 / ●
Pre-examination procedures / 5.4
Are relevant clinical information and diagnosis provided on therequest form? / 5.4.1 / ●
Are there procedures to verify sample identity and integrity? / 5.4.2 / ●
Are there written instructions for the collection and handling of specimens? / 5.4.2, 5.4.3 / ●
Does the laboratory provide a list of available tests to all users of the service? / 5.4.3a(1), 5.5.6 / ●
Are there documentations detailing methods for patientidentification, specimen labeling, specimen preservation and storage before testing? / 5.4.3 / ●
Are specimens inspected to confirm proper labelling and authorization? / 5.4.5 / ●
Are there written criteria, procedures and records forspecimen rejection? / 5.4.8 / ●
Is a documented procedure available for expedited handling of urgent specimens? / 5.4.11 / ●
Are all secondary samples traceable to the primary sample? / 5.4.12 / ●
Examination procedures / 5.5
Has the Laboratory Director or designee reviewed and approved all new policies and procedures as well as substantialchanges to existing documents before implementation? / 5.1.4 , 5.5.2 / ●
Are new lots of reagents validated before being used? / 5.5.2 / ●
Are methods reviewed at least annually? / 5.5.2 / ●
Are written instructions available for all tests performed? / 5.5.3 / ●
Are copies of written instructions located in the work areas and are readily accessible? / 5.5.3 / ●
Are reagents used in accordance with recommendations of themanufacturer? / 5.5.3 / ●
When the recommendations of the manufacturer are not being followed, have the alternative procedures been evaluated? / 5.5.2, 5.5.3 / ●
Assuring quality of examination results / 5.6
Does the laboratory have a documented quality assurance program? / 5.6.1 / ●
Are test systems properly controlled? / 5.6.1 / ●
Are there records that document the results of control procedures? / 5.6.1 / ●
Are records of all quality assurance results being kept? / 4.13.3, 5.6.1 / ●
Are quality control results verified for acceptability before testresults are reported? / 5.6.1 / ●
Are quality control charts kept up to date at all times and regularly reviewed? / 5.6.1 / ●
Does the laboratory participate in appropriate external quality assessment program(s)? / 5.6.4 / ●
Is there a designated person responsible for continual monitoring of quality control and evaluation of proficiencytesting results? / 4.1.5(i), 5.6.4 / ●
If some analyses are done by more than one method or equipment, are there documentation and procedures to ensure that the results are comparable? / 5.6.6 / ●
Are there written criteria for validation of results? / 5.6.6 / ●
Is there evidence to show that nonconformities (e.g., culture or test failures, erroneous reports) are thoroughly investigated and corrective/preventive measures are being taken where necessary? / 4.9.1, 4.10.2, 5.6.7 / ●
Does the laboratory have guidelines for the estimation of uncertainty of measurement (MU) and establish MU for the following tests? / SC28 8.2 / ●
Has your laboratory documented the estimation of uncertainty for tests giving quantitative results such as
- CBP (automated), including Hb, WBC, Plt, MCV and reticulocyte count
- PT, APTT / SC28 8.2 / ●
Post-examination procedures / 5.7
Are results routinely reviewed by someone with supervisory responsibility forclerical errors, absurd results or results requiring special notification beforethey are released? / 5.7.1 / ●
Are primary samples and other relevant laboratory materials retained for appropriate time interval pursuant to the professional, statutory, legislative and HOKLAS requirements? / SC286.3, SC28 9.1 / ●
Reporting of results / 5.8
Can the staff that has performed a test and/or checked a set of results be identified from existing laboratory records? / 5.8.3 / ●
When computer systems are used, are there procedures to check for transcription, calculation, or data entry errors? / 5.8.3 / ●
Are the results on the report legible? / 5.8.3 / ●
Does laboratory retain records (electronic and/or hardcopy format) for an appropriate time interval pursuant to the professional, statutory, legislative and HOKLAS requirements? / 5.8.6, SC28 5.1 / ●
Is a documented procedure available for expedited handling of seriouslyabnormal results? / 5.8.7 / ●
Is the turnaround time set within a reasonable time frame? / 5.8.11 / ●
Are all test reports of tests that require direct input of pathologists reviewed and signed by a qualified haematologist (or qualified pathologist as advised by the HKCPath)? / SC 28 10.1 / ●
For computer auto-validated reports, does the laboratory define and document the person(s) authorising the use of the particular algorithm for the automatic release of the results? Is the authorization for release of auto-validated reports traceable? / SC 28 10.4 / ●
Are the requesters informed on the reports that the results are auto-validated by computer system? / SC 28 10.4 / ●
General Haematology and Coagulation
Technical requirements
Laboratory equipment / 5.3
Does the list of equipment available include the following:
-haematology cell counter? / 5.3.1 / ●
-analyzers (coagulation, electrophoresis)? / 5.3.1 / ●
-spectrophotometer? / 5.3.1 / ●
-stainer? / 5.3.1 / ●
-centrifuge? / 5.3.1 / ●
-pH meter? / 5.3.1 / ●
Does the laboratory have copies of the Manufacturer’s Workand Maintenance Manuals for
-the Automated Haematology System? / 5.3.4 / ●
-the automated system for Reticulocyte Counts? / 5.3.4 / ●
Pre-examination procedures / 5.4
Is the anticoagulant in use appropriate to the test and in the correctfinal concentration? / 5.4.2 / ●
Examination procedures / 5.5
Are measures taken to ensure that anticoagulated blood is adequatelymixed before sampling ? / 5.5.1 / ●
Manual Haematocrit
Has the constant packing time (minimum spin to reach maximum packing of cells) been determined and recorded foreach instrument? / 5.5.1 / ●
Manual Platelet, Red and White Blood Cell Count
Are counting chambers for blood cells examined regularly toensure that the lines are bright and free of scratches? / 5.5.1 / ●
Are correct standard thick glass cover slips used? / 5.5.1 / ●
Is the diluting fluid filtered before use, checked periodically forbackground count and changed when necessary? / 5.5.1 / ●
Is the number of cells counted statistically valid for the test(100 for white cell counts, 1000 for red cell counts, 100 forplatelet counts)? / 5.5.1 / ●
Automated Haematology System: Cell Counting,Cell Size Measurement and Haemoglobin Determination
For semi-automatic systems, is the minimum/maximum time forlysing determined at regular intervals? / 5.5.1 / ●
Are background counts preformed on the diluent and lysingagent to check for contamination? / 5.5.1 / ●
Are procedures available to verify white cell counts that falloutside the action limits? / 5.5.1 / ●
Are adequate measures taken to prevent the possibility of “carry over”? / 5.5.1 / ●
Are performance or tolerance limits defined for each instrument, component or procedure of the system? / 5.5.1 / ●
Blood Film Examination
Are slides for blood film examination adequately identified, i.e. traceable to original sample? / 5.4.12 / ●
Is the quality of blood films satisfactory in respect of (a) staining, (b) debris, and (c) morphology and distribution of cells? / 5.5.1 / ●
Does the report include an evaluation of red cell morphology? / 5.5.1 / ●
Are abnormal slides kept and are they readily accessible? / 5.5.1 / ●
Is an estimation of platelets made from the blood film? / 5.5.1 / ●
When the platelet count falls outside the action limits, are quantitative counts correlated with an estimate from a bloodfilm? / 5.5.1 / ●
Reticulocyte Counts – Manual
Are slides for reticulocyte counts adequately identified, i.e. traceable to original sample? / 5.4.12 / ●
Are blood films stained and examined within 24 hours? / 5.5.1 / ●
Is the reticulocyte stain filtered before use? / 5.5.1 / ●
Is the percentage of reticulocytes based on a count of at least 1000 red cells? / 5.5.1 / ●
Reticulocyte Counts – Automated
Are procedures available to verify reticulocyte counts when they falloutside the action limits? / 5.5.1 / ●
Are there adequate safeguards to prevent the possibility of “carry over”? / 5.5.1 / ●
Are performance or tolerance limits defined for eachinstrument, component or procedure of the system? / 5.5.1 / ●
Blood Films for Malarial Parasites
Are blood films for examination of malarial parasites adequately identified, i.e. traceable to original sample? / 5.4.12 / ●
Are both thick and thin films made? / 5.5.1 / ●
Are appropriate staining techniques used (e.g. Field’s Stain forthick films, Wright, Giemsa stains for thin films; appropriatebuffers etc.)? / 5.5.1 / ●
For thick films, are at least 100 fields examined under oilimmersion before a negative report is issued? / 5.5.1 / ●
Bone Marrow Preparations
Are slides of bone marrow preparation adequately identified, i.e. traceable to original sample? / 5.4.12 / ●
Is the quality of bone marrow films satisfactory with respect to (a) staining, (b) debris, (c) morphology and distribution ofcells? / 5.5.1 / ●
Are histological sections of marrow specimens preparedroutinely (marrow clot and/or trephine biopsy)? / 5.5.1 / ●
Is iron stain routinely performed for iron store assessment? / 5.5.1 / ●
Are facilities available for further investigation(cytochemistry and/or immunophenotyping, etc.)? / 5.5.1 / ●
Cytochemical Studies
Are slides for cytochemical studies adequately identified, i.e. traceable to original sample? / 5.4.12 / ●
Is the quality of blood / bone marrow films satisfactory with respect to (a) staining, (b) debris, (c) morphology and (d) distribution of cells? / 5.5.1 / ●
Are there appropriate controls (internal and/or external) for cytochemical studies? / 5.6.1 / ●
Immunocytochemical Studies
Are slides for immunocytochemical studies adequately identified, i.e. traceable to original sample? / 5.4.12 / ●
Is the quality of blood / bone marrow / cytospin films satisfactorywith respect to (a) staining, (b) debris, (c) morphology and (d) distribution of cells? / 5.5.1 / ●
Are there appropriate controls (internal and/or external) for immunocytochemical studies? / 5.6.1 / ●
Coagulation Systems
If an automated coagulation instrument is used for routinecoagulation studies (e.g. PT, APTT):
-Are guidelines available for determining when otherprocedures should be performed (e.g. specimens that have significant degree of lipaemia, hyperbilirubinaemia, turbidity, etc.)? / 5.5.3 / ●
-Are reference ranges re-established when there is a change in reagentlot? / 5.5.5 / ●
-Is the automated system checked with different levels ofcontrol material at the start of each shift,and when there is a change in reagent? / 5.6.1 / ●
Manual Coagulation Systems
If routine coagulation studies (e.g. PT, APTT) are performed by manual technique:
-Is the temperature of water bath or incubator verified with a certificated thermometer (or equivalent technique)? / 5.5.1 / ●
-Are criteria for accepting duplicate testing results available? / 5.5.3 / ●
-Is the manual coagulation system checked with different levels of control material in duplicate during each 8hour period of patient testing, and when there is a change of reagent? / 5.6.1 / ●
Coagulation Factor Assays
If factor assays are performed:
- Are at least three points plotted for the standard curve? / 5.5.1 / ●
- Are at least two points plotted for the patient’s factor assay curve? / 5.5.1 / ●
Assuring quality of examination procedures / 5.6
Manual Haemoglobin Determination
Are the procedure standardized with reference materials ofknown and certified values? / 5.6.3, 5.6.H / ●
Are at least three points or concentrations used to prepare thestandard curve or to calibrate the readout instruments? / 5.5.1, 5.6.3 / ●
Are calibration curves or calibrations of the instrumentchecked at least monthly and after servicing? / 5.3.9, 5.6.3 / ●
Post-examination procedures / 5.7
Are slides and reports for cytochemical studies filed and readily accessible? / 5.7.2 / ●
Are slides and reports for bone marrow preparations filed and readily accessible? / 5.7.2 / ●
Are slides and reports for immunocytochemical studies filed and readily accessible? / 5.7.2 / ●
Reporting of results / 5.8
Do haematology reports include the appropriate reference ranges? / 5.8.3 / ●
Are diagnosis and classification of haematolymphoid malignancies given according to the WHO classification? / 5.8.4
-Bone Marrow Preparations / ●
-Cytochemical Studies / ●
-Immunocytochemical studies / ●
Cancer Cytogenetics
Management requirements
Quality and technical records / 4.13
Do laboratory records indicate the media used, culture conditions and incubation times for all preparations? / 4.13.3 (d) / ●
Do laboratory records include the number of cells counted, analyzed microscopically and the cells from which photographic or digitalized karyotypes are prepared? / 4.13.3 (d) / ●
Do laboratory records include an assessment of banding resolution to indicate whether metaphase analysis is satisfactory? / 4.13.3 (d) / ●
Technical requirements
Laboratory equipment / 5.3
Does the laboratory have adequate number of image processing systems? / 5.3.1 / ●
Are cell cultures manipulated under conditions that ensuresterility and protect staff? / 5.3.2 / ●
Is there a sterile biologic containment hood that is certifiedannually in the laboratory? / 5.3.2 / ●
Are incubators fitted with alarms or override systems thatprotect against malfunction of temperature and CO2 controls? / 5.3.2 / ●
Are microscopes equipped for high-resolution cytogeneticsanalysis? / 5.3.2 / ●
Is the quality of optical image-capture system high enough to minimize image degradation? / 5.3.2 / ●
Pre-examination procedures / 5.4
Is there at least one unique identifier present on the primarysample? / 5.4.1 / ●
Examination procedures / 5.5
Is each lot of culture medium checked for sterility? / 5.5.1 / ●
Are there independently established or duplicate culturesfor all cancers cytogenetics study to backup against unexpected failures, unless the sample contains insufficientcells to do so? / 5.5.1 / ●
Are culture methods, culture media and additives selectedaccording to the nature of neoplastic disorder under study? / 5.5.1 / ●
Are at least 10 cells analyzed for each case if possible? / 5.5.1 / ●
Are at least 2 karyotypes per mainline and 1 karyotype each from pertinent sidelines generated for each case? / 5.5.1 / ●
Are the band level, quality of banding and resolution sufficientto render the reported interpretation? / 5.5.1 / ●
Post-examination procedures / 5.7
Are fixed preparations of chromosomes and cells stored indefinitely if abnormal,and for 6 months if normal? / SC289.1 / ●
Are slides stored for 2 years after final report if photographic record kept, or 5 yearsotherwise, unless degeneration is evident? / SC289.1 / ●
Are negatives, prints or retrievable electronic media stored indefinitely? / SC289.1 / ●
Reporting of results / 5.8
Does the cytogenetics report contain:
-biological sex of the patient? / 5.8.3 / ●
-description of specimen / tissue studied? / 5.8.3 / ●
-indication for study and relevant clinical data? / 5.8.3 / ●
-number of cells (metaphases) analyzed? / 5.8.3 / ●
-banding method(s) used? / 5.8.3 / ●
-interpretation and clinical significance? / 5.8.3 / ●
-diagnosis and classification according to the WHO classification? / 5.8.4 / ●
Is ISCN 1995 used for description of cytogenetics results? / SC2810.2 / ●
Immunohaematology and blood bank
Management requirements
Advisory services and continual improvement / 4.7, 4.12
Does the institution have a Blood Transfusion Committee? / 4.7, 4.12.4 / ●
Technical requirements
Accommodation and environmental conditions / 5.2
Preservation of blood and blood products
Is emergency power available for each blood storage equipment? / 5.2.4 / ●
If emergency power is not available for each blood storage equipment, are there written emergency procedures to maintain the proper storage of the donor units? / 5.2.4 / ●
Is there controlled access to blood stores? / 5.2.7 / ●
Is the blood storage space adequate for the needs of the facility? / 5.2.9 / ●
Are there standard operation procedures for handling blood outside the blood bank (avoidance of prolonged warming, need for filter)? / 5.2.9 / ●
Are donor units transferred to suitable storage device promptly after receipt? / 5.2.9 / ●
Are there documented policies for returning unused blood? / 5.2.9 / ●
Are donor units segregated in the blood storage device so as to avoid confusion regarding the following? / 5.2.10
- blood group / 5.2.10 / ●
- blood under quarantined / 5.2.10 / ●
- blood suitable for crossmatch / 5.2.10 / ●
- crossmatched blood / 5.2.10 / ●
- rejected blood / 5.2.10 / ●
- autologous blood / 5.2.10 / ●
- expired blood / 5.2.10 / ●
Are blood storage equipment free of materials other than blood products? / 5.2.10 / ●
Are blood inventory control procedures conducted daily to ensure efficientuse of the blood held? / 5.2.10 / ●
Laboratory equipment / 5.3
Are all grouping sera checked for potency and specificity? / 5.3.2 / ●
Are known positive and negative control cells used to check the reactivity of all grouping sera? / 5.3.2 / ●
Is there periodic check on the speed and timing of each serologic centrifuge so as to ensure that the supernatant is clear and the cells are not overpacked? / 5.3.2 / ●
Temperature Recorder
Is a temperature recorder attached to each piece of equipment in whichblood is stored? / 5.3.1, SC28 4.1.1 / ●
Are records of temperature recorder checked daily? / 5.3.2 / ●
Is the temperature sensor of blood refrigerator placed in 150-250 ml of fluid? / 5.3.2 / ●